X hits on this document

61 views

0 shares

0 downloads

0 comments

19 / 21

appropriately and accompanied by adequate monitoring of the disease process is supported by the extensive literature regarding feline and human diabetes. 3, 6-16

Porcine insulin zinc suspension safety in cats was confirmed by the US field studies. Hypoglycemia, lethargy, vomiting, and two injection site reactions were the primary reactions reported. Additional support for the safety of VETSULIN is provided by data from field studies conducted in Australia that included long term evaluation of cats (up to 52 weeks of treatment) and US field study post-study extended use (up to 258 weeks of treatment). Adverse reactions reported during extended use with VETSULIN include hypoglycemia, seizure, lethargy, vomiting/diarrhea, constipation, increased liver enzymes with icterus, weight loss, inappropriate elimination, pancreatitis, decreased appetite/anorexia, limping/abnormal gait, respiratory disease, dyspnea, pleural effusion, sneezing, cough, polyuria, polydipsia, cystitis, and behavioral change.

In years of clinical experience in the more than 20 countries where porcine insulin zinc suspension is currently registered for animal use, few problems have been reported with VETSULIN use in cats. During the 1998-2007 period, 47 cases of adverse events in 50 cats treated with porcine insulin zinc suspension were reported to Intervet International and Intervet Inc. Events included death, seizures, lack of effectiveness/dysregulation, hypoglycemia, allergic or skin reaction, lethargy, vomiting/diarrhea, injection pain, hyperthermia, nystagmus, polyuria, polydipsia, and abnormal behavior.

IV. HUMAN FOOD SAFETY:

This drug is intended for use in dogs and cats, which are non-food animals. Because this new animal drug is not intended for use in food producing animals, CVM did not require data pertaining to drug residues in food (i.e., human food safety) for approval of this NADA.

V.

USER SAFETY:

The product labeling contains the following information regarding safety to humans handling, administering, or exposed to VETSULIN: For use in animals only. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. Accidental injection may cause clinical hypoglycemia. In case of accidental injection, seek medical attention immediately. Exposure to product may induce a local or systemic allergic reaction in sensitized individuals.

Document info
Document views61
Page views61
Page last viewedFri Dec 09 03:29:06 UTC 2016
Pages21
Paragraphs694
Words6325

Comments